Ketogenic Diet in Rheumatoid Arthritis (RA) (KETORA)

February 5, 2024 updated by: University of Oklahoma

Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study

This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73003
        • Oklahoma University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.
  • On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)

Exclusion Criteria:

  • Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
  • Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
  • Insulin use
  • Hospitalization in the 30 days prior to study enrollment
  • Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
  • Malignancy
  • Chronic infection (HIV, hep B/C, etc.)
  • Heavy drinking
  • On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
  • Recent weight loss (>5% in the last 2 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic diet plan
Subjects will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home whole capillary blood ketone/glucose monitors, along with diet records. We will assess adherence based on days in ketosis following these parameters: (BHB ≥ 0.5mM). Adherence will be defined as > 80% of days in ketosis.
Behavioral: Ketogenic diet
Ketogenic diet counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hsCRP
Time Frame: 6 weeks
Systemic marker of inflammation
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAS28-CRP
Time Frame: 6 weeks
RA disease activity measure
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Rheumatology Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020H0090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Ketogenic diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe